Effect of Losartan in Patients With Nonobstructive Hypertrophic Cardiomyopathy
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|ClinicalTrials.gov Identifier: NCT01150461|
Recruitment Status : Completed
First Posted : June 25, 2010
Results First Posted : September 5, 2013
Last Update Posted : September 5, 2013
|Condition or disease||Intervention/treatment||Phase|
|Hypertrophic Cardiomyopathy||Drug: losartan Drug: placebo||Phase 2|
Hypertrophic cardiomyopathy (HCM) is characterized by idiopathic cardiac hypertrophy, heart failure, ischemia even in the absence of epicardial coronary artery disease, and arrhythmias. The pathological features of HCM include hypertrophy and disarray, interstitial fibrosis, and increased arteriolar wall thickness. Hypertrophy and fibrosis are major determinants of morbidity and mortality in hypertrophic cardiomyopathy. Some investigators have demonstrated that interstitial fibrosis and hypertrophy occur secondarily, in response to trophic and mitotic factors in the heart. Therefore, blocking trophic factors may attenuate or potentially reverse hypertrophy and fibrosis in HCM.
Angiotensin II has trophic and profibrotic effects on the heart, and blockade of angiotensin II type I receptors has been shown to attenuate myocardial hypertrophy and fibrosis in acquired cardiac disease in humans and animal models.
We hypothesize that treatment with the selective angiotensin II type receptor antagonist, losartan, will decrease both hypertrophy and fibrosis, improve diastolic function, reduce symptoms, and improve functional status in patients with HCM.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Effect of Losartan in Patients With Nonobstructive Hypertrophic Cardiomyopathy|
|Study Start Date :||February 2007|
|Actual Primary Completion Date :||July 2010|
|Actual Study Completion Date :||July 2010|
Losartan 50 mg b.i.d.
Losartan 50 mg b.i.d
Placebo Comparator: placebo
Other Name: Placebo tablet
- Percentage Change From Baseline in Extent of Left Ventricular Fibrosis at 1 Year as Assessed by Magnetic Resonance Imaging. [ Time Frame: Baseline and 1 year ]
- Percentage Change From Baseline in Left Ventricular Mass at 1 Year as Assessed by Magnetic Resonance Imaging. [ Time Frame: Baseline and 1 year ]
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01150461
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Michael A Fifer, MD||Massachusetts General Hospital|